[Federal Register Volume 59, Number 48 (Friday, March 11, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-5724]
[[Page Unknown]]
[Federal Register: March 11, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180, 185, and 186
[PP 8F3622, FAP 0H5597/P551; FRL-4164-5]
RIN 2070-AC18
Pesticide Tolerances for Clopyralid
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes to reestablish the time-limited
tolerances for residues of the herbicide clopyralid (3,6-dichloro-2-
pyridinecarboxylic acid) in or on the raw agricultural commodities
(RACs) field corn, grain at 1.0 part per million (ppm); field corn,
fodder at 10.0 ppm; and field corn, forage at 3.0 ppm; and on or in the
processed agricultural commodities (PACs) field corn, milling fractions
at 1.5 ppm. These time-limited tolerances were requested by DowElanco.
The time-limited tolerances are proposed to expire on December 31,
1996.
DATES: Written comments and/or objections, identified by the document
control number, [PP 8F3622 and FAP 0H5597/P551], must be received on or
before April 11, 1994.
ADDRESSES: By mail, submit written comments to: Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. In person, deliver comments to: Rm. 1128, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA 22202.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
``Confidential Business Information'' (CBI). Information so marked will
not be disclosed except in accordance with procedures set forth in 40
CFR part 2. A copy of the comment that does not contain CBI must be
submitted for inclusion in the public record. Information not marked
confidential will be included in the public docket by the EPA without
prior notice. The public docket is available for public inspection in
Rm. 1128 at the address given above, from 8 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller, Product
Manager (PM) 23, Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm. 237, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-7830.
SUPPLEMENTARY INFORMATION: In the Federal Register of July 31, 1990 (55
FR 22231), EPA established time-limited tolerances under sections 408
and 409 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a and
348) for residues of the herbicide clopyralid (3,6-dichloro-2-
pyridinecarboxylic acid) in or on the raw agricultural commodities
(RACs) field corn, grain at 0.2 ppm; field corn, fodder at 5.0 ppm;
field corn, forage at 1.0 ppm; and on the processed agricultural
commodity (PAC) field corn, milling fractions at 0.6 ppm. These
tolerances were requested by Dow Chemical U.S.A., P.O. Box 1706,
Midland, MI 48641-1706, and established the maximum permissible level
for residues of the herbicide in or on these RACs and the PACs. These
tolerances expired on June 15, 1991. Meanwhile, the Dow Chemical
Company's pesticide business has been merged with Elanco Products Co.,
a division of Eli Lilly & Co., to form DowElanco. The subject EPA
pesticide petitions have been transferred to DowElanco.
The tolerances for the corn commodities were issued as time-limited
tolerances because EPA did not have adequate data from a rat metabolism
study which was due in January 1991, and the following studies with the
technical product that were due July 31, 1991, 1 year from the date of
publishing these tolerances:
1. A 21-day dermal study in rabbits.
2. A mutagenicity study testing other nontoxic effects.
These toxicological data were submitted and found to be acceptable for
changing the time-limited tolerances to permanent tolerances. Prior to
the expiration of these time-limited tolerances the Agency determined
that the residue chemistry data used to support these tolerances were
suspect data. The residue chemistry data had been generated by Craven
Laboratories. The Agency had received information alleging that Craven
Laboratories may have falsified residue and environmental fate studies.
DowElanco reanalyzed split samples and reported on March 27, 1991, that
they had found in a bridging study that residues of clopyralid in field
corn grain were higher than the established time-limited tolerance of
0.2 ppm and that the residues in or on corn fodder and green forage
were below existing time-limited tolerances of 5.0 and 1.0 ppm,
respectively. There were no bridging data for the processed commodity,
corn milling fractions. The reported residues found in the corn grain
ranged from 0.008 to 0.14 ppm, and the data represented four locations
of use on corn.
DowElanco proposed changing the tolerances for residues of
clopyralid in field corn grain from 0.2 to 0.5 ppm, and in corn green
forage/silage from 1.0 to 1.5 ppm. They determined that the increased
tolerance for field corn grain would reflect an increase in the
utilized ADI, from 5.07 percent to 5.18 percent or a net increase of
0.11 percent of the ADI.
On March 13, 1992, DowElanco submitted a request for an amended
tolerance petition with residue chemistry data, and proposed that based
on the submitted data tolerances for field corn, grain at 1.0 ppm;
field corn, green forage/silage at 3.0 ppm; and field corn, fodder at
10.0 ppm were appropriate. They also proposed food and feed additive
tolerances for field corn milling fractions at 1.2 ppm. EPA issued a
notice in the Federal Register of May 27, 1992 (57 FR 22232), which
announced these proposed tolerances. There were no comments received in
response to the notice of filing.
The Agency determined that the data submitted to support the food
and feed additive tolerances for field corn milling fractions were
inadequate. On March 15, 1993, DowElanco requested reestablishing time-
limited tolerances for residues of clopyralid from its use in field
corn. They proposed that the Agency use data from a similar compound,
6-chloropicolinic acid, to support their request. Based on the
substitute data the Agency has determined that time-limited tolerances
for residues of clopyralid at 1.0 ppm in or on corn, field, grain; 3.0
ppm in or on corn, field, forage; 10.0 ppm in or on corn, field,
fodder; and 1.5 ppm in or on field corn milling fractions would be
acceptable until data from repeated studies on the field corn milling
fractions are submitted. DowElanco has assured the Agency that these
studies will be submitted no later than mid-year, 1994.
The toxicology data listed below were considered in support of
these tolerances.
1. Data listed in the final rule (55 FR 31182) that established the
time-limited tolerances for the use of clopyralid in field corn.
2. A 21-day dermal study in New Zealand white rabbits with a no-
observed-effect level (NOEL) of > 1,000 mg/kg, no systemic toxicity,
and slight dermal irritation.
3. A mutagenicity study, rat hepatocyte unscheduled synthesis
assay, showed negative response at dose levels tested, between 5 X
105 and 1.56 X 102 mole/L.
4. Desposition and metabolism of clopyralid were tested in male and
female rats at a dose of 5 mg/kg (oral). The majority of a radioactive
dose was excreted in 24 hours of all dose groups. Fecal elimination was
minor. Detectable levels of residual radio activity were observed in
the carcass and stomach at 72 hours post-dose. HPLC and TLC analysis of
pooled urine and fecal extracts showed no apparent metabolism of
clopyralid. The study was found acceptable for use in the regulation of
this pesticide.
EPA believes it is inappropriate to establish permanent tolerances
for the use of clopyralid in field corn at this time. Nevertheless, EPA
believes that the existing data support the time-limited tolerances to
December 31, 1996. The proposed time-limited tolerances for the RACs
are appropriate and are being proposed in this rule.
There are no pending regulatory actions against the registration of
this pesticide. The pesticide is useful for the purpose for which these
tolerances are sought. The metabolism of clopyralid in animals is
adequately understood. Adequate analytical methodology, gas
chromatography, is available for enforcement purposes. Because of the
long lead time from establishing these tolerances to publication of the
enforcement methodology in the Pesticide Analytical Manual, Vol. II,
the analytical methodology is being made available in the interim to
anyone interested in pesticide enforcement when requested by mail from:
Calvin Furlow, Public Response and Program Resources Branch, Field
Operations Division (7506C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location and telephone number: Crystal Mall #2, Rm. 1128, 1921
Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-5232.
Based upon the information cited above, the Agency has determined
that the establishment of a time-limited tolerance by amending 40 CFR
part 180 will protect the public health and that establishment of a
time-limited food additive and a time-limited feed additive regulation
by amending 40 CFR parts 185 and 186 will be safe. It is proposed,
therefore, that the tolerance and food and feed additive regulations be
established as set forth below.
Any person who has registered or submitted an application for
registration of a pesticide, under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) as amended, which contains any of the
ingredients listed herein, may request within 30 days after publication
of this document in the Federal Register that this rulemaking proposal
be referred to an Advisory Committee in accordance with section 408(e)
of the Federal Food, Drug, and Cosmetic Act.
Interested persons are invited to submit written comments on the
proposed regulations. Documents relied upon by EPA in issuing this
proposal are available to the public in the Office of Pesticide
Programs docket at the Public Response and Program Resources Branch, at
the address given above. Comments must bear a notation indicating the
document control number, [PP 8F3622 and FAP 0H5597/P551]. All written
comments filed in response to this petition will be available in the
Information Services Section, at the address given above, from 8 a.m.
to 4 p.m., Monday through Friday, except legal holidays.
The Office of Management and Budget has exempted this rule from the
requirements of Executive Order 12866.
Pursuant to the requirements of the Regulatory Flexibility Act
(Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator
has determined that regulations establishing new tolerances or raising
tolerance levels or establishing exemptions from tolerance requirements
do not have a significant economic impact on a substantial number of
small entities. A certification statement to this effect was published
in the Federal Register of May 4, 1981 (46 FR 24950).
List of Subjects in 40 CFR Parts 180, 185, and 186
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Food additives, Feed additives, Pesticides
and pests, Recording and recordkeeping requirements.
Dated: March 2, 1994.
Douglas D. Campt,
Director, Office of Pesticide Programs.
Therefore, it is proposed that chapter I of title 40 of the Code of
Federal Regulations be amended as follows:
PART 180--[AMENDED]
1. In part 180:
a. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
b. In Sec. 180.431, by revising paragraph (b), to read as follows:
Sec. 180.431 Clopyralid; tolerances for residues.
* * * * *
(b) Time-limited tolerances are established as follows for residues
of the herbicide clopyralid (3,6-dichloro-2-pyridinecarboxylic acid) in
or on the following raw agricultural commodities:
------------------------------------------------------------------------
Parts per Expiration
Commodity million date
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Field corn, fodder............................ 10.0 December
31, 1996
Field corn, forage............................ 3.0 December
31, 1996
Field corn, grain............................. 1.0 December
31, 1996
------------------------------------------------------------------------
PART 185--[AMENDED]
2. In part 185:
a. The authority citation for part 185 continues to read as
follows:
Authority: 21 U.S.C. 348.
b. In Sec. 185.1100 by revising paragraph (b), to read as follows:
Sec. 185.1100 Clopyralid.
* * * * *
(b) Time-limited tolerances are established as follows for residues
of the herbicide clopyralid (3,6-dichloro-2-pyridinecarboxylic acid),
in or on the following foods:
------------------------------------------------------------------------
Parts per Expiration
Foods million date
------------------------------------------------------------------------
Field corn, milling fractions................. 1.5 December
31, 1996
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PART 186--[AMENDED]
3. In part 186:
a. The authority citation for part 186 continues to read as
follows:
Authority: 21 U.S.C. 348.
b. In Sec. 186.1100 by revising paragraph (b), to read as follows:
Sec. 186.1100 Clopyralid.
* * * * *
(b) Time-limited tolerances are established as follows for residues
of the herbicide clopyralid (3,6-dichloro-2-pyridinecarboxylic acid),
in or on the following feeds:
------------------------------------------------------------------------
Parts per Expiration
Feeds million date
------------------------------------------------------------------------
Field corn, milling fractions................. 1.5 December
31, 1996
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[FR Doc. 94-5724 Filed 3-10-94; 8:45 am]
BILLING CODE 6560-50-F
